Notice Regarding BAXJECT II Reconstitution Devices Packaged with RIXUBIS.

Support for your patients

Takeda has a variety of resources to help patients who have been prescribed RIXUBIS®, including information, guidance, and resources regarding their treatment.

Image of open box - RIXUBIS offers a free trial program.

FREEDOM OF CHOICE

Your patients may be eligible to receive 4 free doses of RIXUBIS®. This Free Trial Program is for new RIXUBIS patients only. Participants must receive consultation and approval from a healthcare provider.

Download registration form
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Hematology Support Center

Takeda's Hematology Support Center (HSC) is dedicated to helping patients who have been prescribed Takeda hematology products and healthcare providers who have a patient on or ready to start on a Takeda hematology product. HSC offers help with treatment access, as well as educational resources and information for financial assistance programs.
Call 1-888-229-8379 Monday–Friday 8:30AM–8:00PM (ET).

Visit HematologySupport.com

If you have patients that have been prescribed RIXUBIS, here are a few ways that the HSC can help:

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Case Managers

A point of contact who is ready to assist your patients with accessing their treatment

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CoPay Assistance

For eligible commercially insured Takeda patients, Takeda's CoPay Assistance Program covers out-of-pocket expenses related to a patient's Takeda Hematology treatment for which there is a co-pay, such as deductibles and coinsurances†‡§

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Patient Access Manager

A Patient Access Manager is available and can provide one-on-one, personalized insurance education and access information

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Resources and Education

Connecting patients and their caregivers with educational resources-including a Healthcare Educator who can work with them one-on-one if needed

Must meet specific program eligibility requirements and terms and conditions. Certain restrictions apply. Not all Takeda hematology products are available for each program.

These programs are not valid for prescriptions reimbursed, in whole or in part by Medicaid, Medicare, Medigap, VA, DoD, TRICARE or any other federal or state healthcare programs, including state pharmaceutical assistance programs, and where prohibited by health insurance provider or by law. Offer good only in the United States. Offer void where prohibited by law, taxed, or restricted. Takeda reserves the right to rescind, revoke or amend each offer at any time without notice.

§Non-medication expenses, such as ancillary supplies or certain/some administration-related costs, are not eligible.

Patient counseling information

Please go over the information below with your patients before starting them on

Please go over the information below with your patients before starting them on RIXUBIS. This does not include all the important information about RIXUBIS; see the RIXUBIS full Prescribing Information for the full details.

See FDA-approved Patient Labeling (Patient Information and Instructions for Use)
  • Advise patients to report any adverse reactions or problems following RIXUBIS administration to their physician or healthcare provider
  • Inform patients of the early signs of hypersensitivity reactions (including hives, generalized urticaria, chest tightness, wheezing, and hypotension) and anaphylaxis.Instruct patients to discontinue use of the product and contact their physician if these symptoms occur
  • Advise patients to contact their physician or treatment facility for further treatment and/or assessment if they experience a lack of a clinical response to factor IX replacement therapy, as in some cases this may be a manifestation of an inhibitor
  • Ask patients to follow the specific preparation and administration procedures provided by their physician
  • Inform patients to follow the recommendations in the FDA-approved patient labeling
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What is RIXUBIS?1

RIXUBIS is a medicine used to replace clotting factor (Factor IX) that is missing in people with hemophilia B. Hemophilia B is also called congenital factor IX deficiency or Christmas

RIXUBIS is a medicine used to replace clotting factor (Factor IX) that is missing in people with hemophilia B. Hemophilia B is also called congenital factor IX deficiency or Christmas disease. Hemophilia B is an inherited bleeding disorder that prevents blood from clotting normally.

RIXUBIS is used to prevent and control bleeding in people with hemophilia B. Your healthcare provider may give you RIXUBIS when you have surgery. RIXUBIS can reduce the number of bleeding episodes when used regularly (prophylaxis).

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Who should not use RIXUBIS?1

You should not use RIXUBIS if you:

You should not use RIXUBIS if you:

  • Are allergic to hamsters
  • Are allergic to any ingredients in RIXUBIS

Tell your healthcare provider if you are pregnant or breastfeeding because RIXUBIS may not be right for you.

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What should you tell your doctor before using RIXUBIS?1

You should tell your healthcare provider if you:

You should tell your healthcare provider if you:

  • Have or have had any medical problems
  • Take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements or herbal remedies
  • Have any allergies, including allergies to hamsters
  • Are breastfeeding. It is not known if RIXUBIS passes into your milk and if it can harm your baby
  • Are pregnant or planning to become pregnant. It is not known if RIXUBIS may harm your unborn baby
  • Have been told that you have inhibitors to factor IX (because RIXUBIS may not work for you)
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How should you infuse RIXUBIS?1

RIXUBIS is given directly into the bloodstream.
RIXUBIS should be administered as ordered by your healthcare provider. You should

RIXUBIS is given directly into the bloodstream.

RIXUBIS should be administered as ordered by your healthcare provider. You should be trained on how to do infusions by your healthcare provider or hemophilia treatment center. Many people with hemophilia B learn to infuse RIXUBIS by themselves or with the help of a family member.

Your healthcare provider will tell you how much RIXUBIS to use based on your weight, the severity of your hemophilia B, and where you are bleeding.

You may have to have blood tests done after getting RIXUBIS to be sure that your blood level of factor IX is high enough to clot your blood.

Call your healthcare provider right away if your bleeding does not stop after taking RIXUBIS.

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What are the possible side effects of RIXUBIS?1

Allergic reactions may occur with RIXUBIS. Call your doctor or get emergency treatment right away if you get a rash or hives, itching, tightness of the throat, chest pain or tightness,

Allergic reactions may occur with RIXUBIS. Call your doctor or get emergency treatment right away if you get a rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea, or fainting. Some common side effects of RIXUBIS were unusual taste in the mouth and limb pain. Tell your healthcare provider about any side effects that bother you or do not go away. These are not all the side effects possible with RIXUBIS. You can ask your healthcare provider for information that is written for healthcare professionals.

Your body may form inhibitors to factor IX. An inhibitor is part of the body's defense system. If you form inhibitors, it may stop RIXUBIS from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to factor IX.

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What are the RIXUBIS dosage strengths?1

RIXUBIS comes in five different dosage strengths: 250 International Units (IU), 500 IU, 1000 IU, 2000 IU, and 3000 IU. The actual strength will be imprinted on the label and on

RIXUBIS comes in five different dosage strengths: 250 International Units (IU), 500 IU, 1000 IU, 2000 IU, and 3000 IU. The actual strength will be imprinted on the label and on the box. The five different strengths are color coded, as follows:

Always check the actual dosage strength printed on the label to make sure you are using the strength prescribed by your healthcare provider. Always check the expiration date printed on the box. Do not use the product after the expiration date printed on the box.

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How should you store RIXUBIS?1

Store at refrigerated temperature [2°C to 8°C (36°F to 46°F)] or room temperature [not to exceed 30°C (86°F)] for up to 36 months. Do not freeze.
  • Store at refrigerated temperature [2°C to 8°C (36°F to 46°F)] or room temperature [not to exceed 30°C (86°F)] for up to 36 months. Do not freeze
  • Do not use after the expiration date printed on the carton or vial
  • Reconstituted product (after mixing dry product with wet diluent) must be used within 3 hours and cannot be stored or refrigerated. Discard any RIXUBIS left in the vial at the end of your infusion

Medicines are sometimes prescribed for purposes other than those listed here. Do not use RIXUBIS for a condition for which it is not prescribed. Do not share RIXUBIS with other people, even if they have the same symptoms that you have.

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Indications

RIXUBIS® [Coagulation Factor IX (Recombinant)] is an antihemophilic factor indicated in adults and children with hemophilia B for:

  • On-demand treatment and control of bleeding episodes
  • Perioperative management of bleeding
  • Routine prophylaxis to reduce the frequency of bleeding episodes...

RIXUBIS® [Coagulation Factor IX (Recombinant)] is an antihemophilic factor indicated in adults and children with hemophilia B for...

Selected Important Risk Information

CONTRAINDICATIONS

RIXUBIS is contraindicated in patients who have:

RIXUBIS is contraindicated in patients who have...

  • Known hypersensitivity to RIXUBIS or its excipients including hamster protein
  • Disseminated Intravascular Coagulation (DIC)
  • Signs of fibrinolysis